Iit was reported that the foley catheter probe design was defective as it was missing a plastic part in the part where the balloon was inflated, the washer that indicates the measurement of the probe and lot was missing.The catheter package was not opened and was not used on the patient.As per the additional information received on 19mar2024, the customer confirmed that the washer was not broken but it did not come.
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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